A Study of Pemetrexed in Recurrent Cervical Adenocarcinomas

• Sponsor: Western Regional Medical Center (Other)
• Overall Status: Terminated
• CT.gov ID: NCT02868892
• Collaborator: (none)
• Enrollment: 6
• Location: 1
• Arm: 1
• Duration (Months): 24
• Patients Per Site Per Month: 0.2

Study Details

Study Description

Brief Summary

Patients with advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix will receive Pemetrexed.

Condition or Disease	Intervention/Treatment	Phase
Adenocarcinoma of the Cervix; Adenosquamous Cell Carcinoma of the Cervix	Drug: Pemetrexed	Phase 2

Detailed Description

Patients will receive Pemetrexed 500 mg/m2 every three week.

On initiation of pemetrexed, on day one of first chemotherapy cycle, patients will begin taking folic acid at a dose of 350 to 600 mcg daily as well as receive an intramuscular injection of 1000 mcg of vitamin B12, with subsequent vitamin B12 injections given every 9 weeks while on study.

Study Design

• Study Type: Interventional
• Actual Enrollment: 6 participants
• Allocation: N/A
• Intervention Model: Single Group Assignment
• Masking: None (Open Label)
• Primary Purpose: Treatment
• Official Title: A Phase II Study of Pemetrexed in Recurrent Cervical Adenocarcinomas
• Study Start Date: Jul 1, 2015
• Actual Primary Completion Date: Jul 1, 2017
• Actual Study Completion Date: Jul 1, 2017

Arms and Interventions

Arm	Intervention/Treatment
Experimental: Pemetrexed Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle.	Drug: Pemetrexed; Pemetrexed 500 mg/m2; Other Names: Alimta

Outcome Measures

Primary Outcome Measures

1. Progression Free Survival [2 years]

   Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.

Secondary Outcome Measures

1. Response Rate [2 years]

   Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.

2. Overall Survival [2 years]

   Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.

Eligibility Criteria

Criteria

• Ages Eligible for Study: 18 Years and Older
• Sexes Eligible for Study: All
• Accepts Healthy Volunteers: No

Inclusion Criteria:

1. Patients must have had advanced or recurrent adenocarcinoma or adenosquamous cell carcinoma of the cervix with documented disease progression

2. Patients must have had measurable disease defined as at least one lesion that could be accurately measured in at least one dimension, which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, computerized tomography (CT), and magnetic resonance imaging(MRI) or 10 mm when measured by spiral CT

3. 18 years of age or older

4. Eastern Cooperative Oncology Group (ECOG) performance status score < 2 and a life expectancy >3 months

5. Life expectancy ≥ 12 weeks

6. Participants must have measureable disease by RECIST criteria

7. Absolute neutrophil count > 1500 mm3, platelet count ≥ 100×109 L, hemoglobin ≥ 8.5 g/dL

8. Creatinine clearance ≥ 45 mL/min using the standard Cockcroft and Gault formula (below) or glomerular filtration rate (GFR) measured by

Tc99m-diethylenetriaminepentacetate (DPTA) serum clearance method:

1. Males: [140 - Age in years] × Actual Body Weight (kg) 72 × Serum Creatinine (mg/dL)

2. Females: Estimated creatinine clearance for males × 0.85

3. Total bilirubin ≤ 2 mg/dL, aspartate transaminase (AST) and alanine transaminase (ALT) AST/ALT ≤ 5 times the upper limit of normal range

4. At least 21 days from administration of chemotherapy

5. No remaining grade 2 or higher toxicity from prior cancer therapies unless judged to be clinically insignificant by the Principal Investigator

6. At least four (4) weeks from prior major surgery

7. Willingness to provide permission to access archived tumor samples and additional blood samples for evaluation of Foundation One Analysis where available Enterprise wide.

8. Women of child-bearing potential (i.e., women who are pre-menopausal or not surgically sterile) must be willing to use an acceptable contraceptive method (abstinence, oral contraceptive or double barrier method) for the duration of the study and for 30 days following the last dose of study drug, and must have a negative urine or serum pregnancy test within 2 weeks prior to beginning treatment on this trial.

Exclusion Criteria:

1. Uncontrolled cardiac disease, congestive heart failure, angina, arrhythmias or hypertension.

2. Myocardial infarction or unstable angina within 2 months of treatment.

3. Known human immunodeficiency virus (HIV) infection or chronic active Hepatitis B or C (patients are NOT required to be tested for the presence of such viruses prior to therapy on this protocol).

4. Active clinically serious infection > CTCAE (version 4.03) Grade 2.

5. Thrombotic or embolic events such as a cerebrovascular accident including transient ischemic attacks within the past 6 months.

6. Pulmonary hemorrhage/bleeding event ≥ CTCAE Grade 2 within 4 weeks of first dose of study drug.

7. Any other hemorrhage/bleeding event ≥ CTCAE Grade 3 within 4 weeks of first dose of study drug.

8. Serious non-healing wound, ulcer, or bone fracture.

9. Major surgery, open biopsy or significant traumatic injury within 4 weeks of first study drug.

10. Inability to complete informed consent process and adhere to the protocol treatment plan and follow-up requirements.

11. Concurrent severe illness such as active infection, or psychiatric illness/social situations that would limit safety and compliance with study requirements.

Contacts and Locations

Locations

	Site	City	State	Country	Postal Code
1	Western Regional Medical Center, Inc.	Goodyear	Arizona	United States	85338

Sponsors and Collaborators

• Western Regional Medical Center

Investigators

• Principal Investigator: John Farley, MD, Western Regional Medical Center

Study Documents (Full-Text)

• Study Protocol and Statistical Analysis Plan - Mar 29, 2016

More Information

Publications

None provided.

• Responsible Party: Western Regional Medical Center
• ClinicalTrials.gov Identifier: NCT02868892
• Other Study ID Numbers: CWG2014034 Pemetrexed Cervica
• First Posted: Aug 16, 2016
• Last Update Posted: Nov 2, 2018
• Last Verified: Oct 1, 2018

• Individual Participant Data (IPD) Sharing Statement: Yes
• Plan to Share IPD: Yes
• Additional relevant MeSH terms: Adenocarcinoma; Carcinoma, Adenosquamous; Pemetrexed

Study Results

Participant Flow

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
Period Title: Overall Study
STARTED	6
COMPLETED	0
NOT COMPLETED	6

Baseline Characteristics

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
Overall Participants	6
Age (Count of Participants)
<=18 years	0 0%
Between 18 and 65 years	6 100%
>=65 years	0 0%
Age (years) [Mean (Full Range) ]
Mean (Full Range) [years]	54
Sex: Female, Male (Count of Participants)
Female	6 100%
Male	0 0%
Ethnicity (NIH/OMB) (Count of Participants)
Hispanic or Latino	2 33.3%
Not Hispanic or Latino	1 16.7%
Unknown or Not Reported	3 50%
Region of Enrollment (participants) [Number]
United States	6 100%

Outcome Measures

1. Primary Outcome

Title	Progression Free Survival
Description	Evaluate the progression free survival of recurrent cervical adenocarcinoma. Progression-Free Survival is defined as the period of time from the date of first study drug administration to the date that the subject is determined to have progressive disease or death due to any cause.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
Measure Participants	0

2. Secondary Outcome

Title	Response Rate
Description	Evaluate the response rate for recurrent cervical adenocarcinomas treated with pemetrexed. Measurable disease is defined as at least one lesion that can be accurately measured in at least one dimension which must have been 20 mm when measured by conventional techniques including palpation, plain X-ray, CT, and MRI or 10 mm when measured by spiral CT.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
Measure Participants	0

3. Secondary Outcome

Title	Overall Survival
Description	Evaluate Overall survival for recurrent cervical adenocarcinomas treated with pemetrexed.
Time Frame	2 years

Outcome Measure Data

Analysis Population Description

Investigator no longer at site. Study was closed with no PI transfer, data collection or statistical analysis.

Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
Measure Participants	0

Adverse Events

Time Frame	6-12 months
Arm/Group Title	Pemetrexed
Arm/Group Description	Pemetrexed 500 mg/m2 will be administered on an outpatient basis on an every three week schedule. Pemetrexed will be administered as a 10 minutes intravenous (IV) infusion in (for 500-mg vial) 100 ml of saline via peripheral vein or central line on Day 1 of each 21 day cycle. Pemetrexed: Pemetrexed 500 mg/m2
All Cause Mortality
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Serious Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	0/6 (0%)
Other (Not Including Serious) Adverse Events
	Pemetrexed
	Affected / at Risk (%)	# Events
Total	0/6 (0%)

Limitations/Caveats

[Not Specified]

More Information

Certain Agreements

All Principal Investigators ARE employed by the organization sponsoring the study.

There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.